MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
FDA 510(k) clearance K010413 · decided 2001-08-02
Clearance details
- K-number
- K010413
- Device name
- MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
- Applicant
- Konica Minolta Sensing, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-12
- Decision date
- 2001-08-02
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bailey, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error recall (Z-0289-04) | Minolta Corp | 2004-07-20 |
| Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error recall (Z-0290-04) | Minolta Corp | 2004-07-20 |